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National Model Clinical Governance Framework

Published by the Australian Commission on Safety and Quality in Health CareLevel 5, 255 Elizabeth Street, Sydney NSW 2000Phone: (02) 9126 3600 Fax: (02) 9126 3613Email: [email protected] Website: www.safetyandquality.gov.au ISBN: 978-1-925665-18-5

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DisclaimerThe content of this document is published in good faith by the Australian Commission on Safety and Quality in Health Care for information purposes. The document is not intended to provide guidance on particular healthcare choices. You should contact your healthcare provider on particular healthcare choices. This document includes the views or recommendations of its authors and third parties. Publication of this document by the Commission does not necessarily reflect the views of the Commission, or indicate a commitment to a particular course of action. The Commission does not accept any legal liability for any injury, loss or damage incurred by the use of, or reliance on, this document.

AcknowledgementThe Commission would like to thank all of our partners for their contributions to the development of the NSQHS Standards and their continuing commitment to improving safety and quality across the Australian healthcare system.This document was released in November 2017.

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National Model Clinical Governance Framework i

Contents

Foreword ii

Summary iii

Introduction 1

Corporate (organisational) governance of health service organisations 3

Key concepts 3

Responsibilities of governing bodies for corporate governance 3

Clinical governance and the National Model Clinical Governance Framework 5

Clinical governance as an integrated component of organisational governance 5

Components of the Clinical Governance Framework 6

Importance of culture in clinical governance 8

Roles and responsibilities for clinical governance 9

Governance, leadership and culture 11

Patient safety and quality improvement systems 12

Clinical performance and effectiveness 14

Safe environment for the delivery of care 16

Partnering with consumers 17

Appendix: NSQHS Standards 19

Acknowledgements 30

Glossary 31

References 35

National Model Clinical Governance Frameworkii

Foreword

Australians enjoy good health outcomes, and generally trust health service organisations and clinicians to provide safe and high-quality health care. However, safety and quality lapses continue to occur that can have a major affect on people’s lives and on the broader health system.

Since 2015, a number of state and territory governments have engaged the Australian Commission on Safety and Quality in Health Care to review identified patient safety problems. These reviews have shown that some health service organisations have problems implementing key clinical governance processes. Issues that have been identified include problems with:• Implementing an open disclosure response

consistent with national and local standards• Ensuring that incident management and

investigation systems can provide adequate surveillance to recognise major safety failures or risks

• Implementing corrective action in response to identified patient safety risks and failures

• Establishing complaint management systems that include a partnership with patients and carers

• Ensuring a robust and positive safety culture• Clearly understanding the roles and

responsibilities of boards, the executive, clinical teams and clinicians in clinical governance.

The National Model Clinical Governance Framework has been developed to improve these issues. It provides a consistent national framework for clinical governance that is based on the National Safety and Quality Health Service Standards. It supports a shared understanding of clinical governance among everyone working in health service organisations, including clinicians, managers and members of the governing body. This will ensure that clinical governance systems are implemented effectively, and support safer and better care for patients and consumers.

We take this opportunity to thank members of the Advisory Panel who provided expert advice in the development of the National Model Clinical Governance Framework for their time and expertise.

Ms Wendy Harris QC Chair National Model Clinical Governance Framework Advisory Panel

Professor Villis Marshall AC Chair Australian Commission on Safety and Quality in Health Care

National Model Clinical Governance Framework iii

Summary

Patients, consumers and the community trust clinicians and health service organisations to provide safe, high-quality health care.

Clinical governance is the set of relationships and responsibilities established by a health service organisation between its state or territory department of health, governing body, executive, workforce, patients, consumers and other stakeholders to ensure good clinical outcomes. It ensures that the community and health service organisations can be confident that systems are in place to deliver safe and high-quality health care, and continuously improve services.

Clinical governance is an integrated component of corporate governance of health service organisations. It ensures that everyone – from frontline clinicians to managers and members of governing bodies, such as boards – is accountable to patients and the community for assuring the delivery of health services that are safe, effective, integrated, high quality and continuously improving.

To support the delivery of safe and high-quality care for patients and consumers, the Australian Commission on Safety and Quality in Health Care has developed the National Model Clinical Governance Framework (the Clinical Governance Framework). The Clinical Governance Framework is based on the National Safety and Quality Health Service (NSQHS) Standards – in particular, the Clinical Governance Standard and the Partnering with Consumers Standard. The Clinical Governance Framework has five components:• Governance, leadership and culture• Patient safety and quality improvement systems• Clinical performance and effectiveness• Safe environment for the delivery of care• Partnering with consumers.

The elements in the Clinical Governance Framework are also mandatory for health service organisations that need to meet the requirements of the NSQHS Standards when they are accredited. As with the NSQHS Standards, however, the Clinical Governance Framework does not specify how a health service organisation should develop or implement its clinical governance systems. Each health service organisation needs to put in place strategies to meet the requirements of the NSQHS Standards for clinical governance that consider its local circumstances. The Clinical Governance Framework builds on the NSQHS Standards, providing more information about corporate and clinical governance, and roles and responsibilities for people within a health service organisation. Further resources will also be available to support the Clinical Governance Framework for specific target audiences and settings.

National Model Clinical Governance Framework 1

Introduction

Health care in Australia is provided by teams of clinicians working in partnership with patients, families and carers. It is delivered in a wide variety of public and private organisations, ranging from sole proprietorships to large statutory corporations and public companies.

Patients, consumers and the community trust clinicians and health service organisations to provide safe, high-quality health care, and most Australians have access to such care. Australia’s clinicians are highly regarded as skilled professionals who are committed to meeting the healthcare needs of their patients. Key safety and quality risks have been identified, and strategies exist to improve the safety and quality of health care. Although there is a strong system-wide commitment to continuous improvement, delays and problems with implementation mean that failures in safety and quality continue to occur.

Australia generally performs well in international comparisons about health.1 However, although most health care in Australia leads to good outcomes, patients do not always receive the care that is most appropriate for them, and preventable adverse events occur across the Australian healthcare system.2 Lapses in safety and quality, and unwarranted variation in health care provided to different populations within Australia have substantial costs, in terms of both the effect on people’s lives and financially.2,3

The delivery of health care is a complex endeavour. Contemporary models of care are sophisticated and rapidly changing, as are the expectations of patients and consumers. Health service organisations such as hospitals sit within intricate webs of different types of services across tertiary, secondary and primary sectors. Patients and consumers move between these services and sectors, and safety and quality risks exist at all points on these journeys.4-6

Traditionally, ensuring an acceptable standard of safety and quality was viewed as predominantly the responsibility of individual clinicians. Now, the importance of the individual and collective roles and responsibilities of patients, consumers, clinicians, healthcare teams, managers, directors, governing bodies and departments of health is well recognised.

Although the safety and quality of health care provided to each patient are highly dependent on the skills and performance of individual clinicians, safety and quality are also a professional and organisational responsibility. They rely on effective governance and management processes, and the establishment of systems involving a large number of contributors in health service organisations and across the health system.

To support the delivery of safe and high-quality health care, and the best possible outcomes for patients in this complex environment, the Australian Commission on Safety and Quality in Health Care (the Commission) has developed this National Model Clinical Governance Framework (Clinical Governance Framework) for public and private healthcare organisations in the acute sector.

The Clinical Governance Framework is based on the National Safety and Quality Health Service (NSQHS) Standards (second edition), particularly the Clinical Governance Standard and the Partnering with Consumers Standard.7 As part of the complete set of NSQHS Standards, these two standards constitute a complete and robust clinical governance framework.

Purpose of the Clinical Governance Framework

The purpose of the Clinical Governance Framework is to ensure that patients and consumers receive safe and high-quality health care by describing the elements that are essential for acute health service organisations to achieve integrated corporate and clinical governance systems. Through these systems, organisations and individuals are accountable to patients and the community for continuously improving the safety and quality of their services. The Clinical Governance Framework: • Defines clinical governance• Provides the context for clinical governance

being an integrated component of corporate governance

National Model Clinical Governance Framework2

• Describes the key components of a clinical governance framework, based on the NSQHS Standards

• Discusses the role of culture in supporting good clinical governance

• Outlines the roles and responsibilities of, and essential partnership between, patients and consumers, clinicians, managers, and governing bodies (such as boards) in implementing effective clinical governance systems in health service organisations.

Application and use of the Clinical Governance Framework

It is mandatory for all Australian hospitals and day procedure services to be assessed through an independent accreditation process to determine whether they have implemented the NSQHS Standards. Therefore, the elements in the Clinical Governance Framework are also mandatory for these health service organisations.

As with the NSQHS Standards, the Clinical Governance Framework does not specify how a health service organisation should develop or implement its clinical governance systems. Rather, it outlines the components of a clinical governance framework to enable health service organisations to develop and implement their own governance systems, considering local needs, values and the context in which services are provided.

The Clinical Governance Framework builds on the NSQHS Standards, providing more information about corporate and clinical governance, and roles and responsibilities relating to clinical governance for people within a health service organisation.

Detailed guidance about strategies to meet the requirements of the NSQHS Standards is included in the guides for hospitals and other types of health service organisations that are currently being developed by the Commission. The Clinical Governance Framework should be used with these documents.

The Clinical Governance Framework can be used by clinicians, managers, executives, governing bodies, and state and territory departments of health to

support effective clinical governance and improve the safety and quality of care.

The Clinical Governance Framework will be supported by resources developed by the Commission for specific target audiences, including members of governing bodies (such as boards), clinicians and consumers. Resources will also be developed to support application of the Clinical Governance Framework in specific settings, such as private hospitals and day procedure services.

The Clinical Governance Framework applies to public and private health services in the acute sector. As noted earlier, however, the delivery of health care in Australia is complex, and patients move between different types of services across acute and primary sectors. Because of this complexity, and the safety and quality risks that exist at these transition points4-6, there is a need to work towards an integrated system of clinical governance for the whole health system. The Clinical Governance Framework is a starting point for future work that will explore clinical governance in primary care.8

Definition of clinical governance

The definition of clinical governance that underpins the Clinical Governance Framework is as follows:

Clinical governance is the set of relationships and responsibilities established by a health service organisation between its state or territory department of health (for the public sector), governing body, executive, clinicians, patients, consumers and other stakeholders to ensure good clinical outcomes.9 It ensures that the community and health service organisations can be confident that systems are in place to deliver safe and high-quality health care, and continuously improve services.

Clinical governance is an integrated component of corporate governance of health service organisations. It ensures that everyone – from frontline clinicians to managers and members of governing bodies, such as boards – is accountable to patients and the community for assuring the delivery of health services that are safe, effective, integrated, high quality and continuously improving.


Corporate (organisational) governance of health service organisations

Clinical governance is an integrated component of corporate governance. This section provides an overview of key concepts and elements of corporate governance, particularly regarding the responsibilities of governing bodies such as boards.

Key concepts

A large proportion of Australian health care is delivered in public sector and private sector organisations governed by bodies such as boards of directors. Boards are generally well versed in the concepts and practices of corporate governance, which is recognised as a responsibility of governing bodies, and is distinguished from responsibility for management and service delivery.

The concept of clinical governance is best understood as founded in, and consistent with, broader concepts of corporate or organisational governance.*

Robert Tricker is credited with creating the term ‘corporate governance’. According to Tricker10:

The governance role is not concerned with the running of the company, per se, but with giving overall direction to the enterprise, with overseeing and controlling the executive actions of management and with satisfying legitimate expectations of accountability and regulation by interests beyond the corporate boundaries.

Corporate governance encompasses the establishment of systems and processes that shape, enable and oversee management of an organisation. It is the activity, undertaken by governing bodies such as boards, of formulating strategy, setting policy, delegating responsibility, overseeing management, and ensuring that appropriate risk management and accountability arrangements are in place throughout the organisation.

* In the public sector, since not all health service organisations are corporations with a governing board, the term ‘organisational governance’ can be used, rather than ‘corporate governance’.

Management, on the other hand, is concerned with doing – with coordinating and managing the day-to-day operations of the business.11

Responsibilities of governing bodies for corporate governance

Good governance is clearly recognised as a responsibility of governing bodies such as boards:

It is the board’s responsibility to ensure good governance and to account to [shareholders] for their record in this regard.12

Management has an operational focus, whereas governance has a strategic focus. Managers run organisations, whereas their boards ensure that organisations are run well and in the right direction.

The governing body derives its authority to conduct the business of the organisation from the enabling legislation and the organisation’s constitutional documents, where applicable. The board ‘governs’ the organisation by establishing a ‘governance system’, elements of which are implemented by the board itself, leaders and the workforce at all levels of the organisation. As part of its governance system, the governing body:• Establishes a strategic and policy framework• Delegates responsibility for operating the

organisation to the chief executive officer, who, in turn, delegates specific responsibilities to members of the workforce

• Supervises the performance of the chief executive officer

• Monitors the performance of the organisation and ensures that there is a focus on continuous quality improvement.


The model described by Tricker for the role and functions of governance highlights both the forward-looking (leadership and performance) and retrospective (accountability and conformance) elements of good governance (Figure 1).10

The generally accepted governance duties and responsibilities of a governing body such as a board include:• Appointing a chief executive officer, supporting

them to lead the organisation and evaluating their performance

• In consultation with management, setting and reviewing organisational plans and strategies

• Endorsing and approving budgets, and major financial and organisational decisions

• Ensuring that the organisation is being properly managed, including that

– systems of production or service delivery are well designed and fit for purpose

– services meet desired standards – the organisation meets its compliance

obligations• Challenging the assumptions of management

• Reviewing and monitoring performance of the control framework to ensure that major risks are identified and managed

• Ensuring that there is an ongoing focus on quality improvement

• Evaluating reports, and reviewing feedback, suggestions and complaints

• Ensuring the continuing development of the executive management team

• Planning for succession• Communicating with, and being accountable to,

internal and external stakeholders.

Although it is ultimately the governing body’s responsibility to ensure good corporate governance, many governance responsibilities are distributed throughout the organisation. For example, people at all levels of a health service organisation help to design and implement risk management, performance monitoring and audit programs, which are key elements of good governance systems. It is the board’s responsibility, however, to ensure that the overall governance system is implemented effectively, and that the board is accountable for the outcomes and performance of the organisation.

Figure 1: Role and functions of governing bodies in governance


Clinical governance and the National Model Clinical Governance Framework

This section describes how clinical governance is an integrated component of broader corporate governance and sets out the key elements of the Clinical Governance Framework, based on the NSQHS Standards.

Clinical governance as an integrated component of organisational governance

The responsibility of a governing body such as a board for clinical governance is an integrated element of its overall responsibility and accountability to govern the organisation (Figure 2). As a component of broader systems for corporate governance, clinical governance involves a complex set of leadership behaviours, policies, procedures, and monitoring and improvement mechanisms that are directed towards ensuring good clinical outcomes.

The clinical governance system of a health service organisation therefore needs to be conceptualised as a system within a system – a clinical governance system within a corporate governance system.

Under this model, it is important to recognise the following:• Clinical governance is of equivalent importance

to financial, risk and other business governance• Decisions about other aspects of corporate

governance can have a direct affect on the safety and quality of care, and decisions about clinical care can have a direct affect on other aspects of corporate governance, such as financial performance and risk management

• Governing bodies are ultimately responsible for good corporate (including clinical) governance

• Governing bodies cannot govern clinical services well without the deep engagement of skilled clinicians working at all levels of the organisation

• Clinicians, managers and members of governing bodies have individual and collective responsibilities for ensuring the safety and quality of clinical care; as well as being reflected in the NSQHS Standards, many of these responsibilities are specified in relevant professional codes of conduct.

Figure 2: Corporate governance responsibilities

Although it is ultimately the responsibility of a governing body to set up a sound clinical governance system, and be accountable for outcomes and performance within this system, implementation involves contributions by individuals and teams at all levels of the organisation. There is also reliance on well-designed systems that deliver, monitor and account for the safety and quality of patient care.


The application of clinical governance systems to achieve good clinical outcomes requires a focus on both what happens within a health service organisation, and the integration and linkages of the health service organisation within a network of other health service organisations in the acute and primary care sectors. This network may include general practitioners, other specialists, allied health providers and aged care homes.

Components of the Clinical Governance Framework

The Clinical Governance Framework is based on the NSQHS Standards (2nd ed.) – in particular, the Clinical Governance Standard and the Partnering with Consumers Standard.

The NSQHS Standards were developed by the Commission in consultation and collaboration with states and territories, the private sector, executives and managers, clinical experts, patients, and carers. The primary aims of the NSQHS Standards are to protect the public from harm and to improve the quality of health service provision. Since 2013, it has been mandatory for all Australian hospitals and day procedure services to be assessed through an independent accreditation process to determine whether they have implemented the NSQHS Standards.

To fully apply the NSQHS Standards in a health service organisation, governing bodies, management, patients, consumers, clinicians and clinical teams need to be engaged in the implementation of actions set out in the NSQHS Standards.

In the context of the complete set of NSQHS Standards, the Clinical Governance Standard and the Partnering with Consumers Standard together ensure the creation of clinical governance systems within healthcare organisations that:• Are fully integrated within overall corporate

governance systems• Are underpinned by robust safety and quality

management systems• Maintain and improve the reliability, safety and

quality of health care• Improve health outcomes for patients.

To achieve a complete and robust clinical governance system, actions to meet the Clinical Governance Standard and the Partnering with Consumers Standard need to be supported by actions to meet the other six NSQHS Standards.

As reflected in the NSQHS Standards, the Clinical Governance Framework has five components (Figure 3). The central component relates to patients and consumers, who are at the centre of the Clinical Governance Framework. The five components of the Clinical Governance Framework are as follows:• Governance, leadership and culture – integrated

corporate and clinical governance systems are established, and used to improve the safety and quality of health care for patients

• Patient safety and quality improvement systems – safety and quality systems are integrated with governance processes to actively manage and improve the safety and quality of health care for patients

• Clinical performance and effectiveness – the workforce has the right qualifications, skills and supervision to provide safe, high-quality health care to patients

• Safe environment for the delivery of care – the environment promotes safe and high-quality health care for patients

• Partnering with consumers – systems are designed and used to support patients, carers, families and consumers to be partners in healthcare planning, design, measurement and evaluation; elements of this component include

– clinical governance and quality improvement systems to support partnering with consumers

– partnering with patients in their own care – health literacy – partnering with consumers in organisational

design and governance.

Detailed information about each component of the Clinical Governance Framework, including strategies for improvement, is available in the guides developed by the Commission to support the NSQHS Standards.

The actions specified in the NSQHS Standards for the Clinical Governance Standard and the Partnering with Consumers Standard are in the Appendix. These actions comprise the Clinical Governance Framework.


Figure 3: National Model Clinical Governance Framework


Importance of culture in clinical governance

The NSQHS Standards specify the actions that a health service organisation needs to take to develop and set up systems for good clinical governance. Culture, however, is just as important in clinical governance in ensuring that patients and consumers receive safe and high-quality care.

Culture is a complex and contested concept that has many different definitions. Central to most of these definitions is that culture consists of:

… the values, beliefs and assumptions shared by occupational groups. These shared ways of thinking are then translated into common and repeated patterns of behaviour: patterns of behaviour that are in turn maintained and reinforced by the rituals, ceremonies and rewards of everyday organisational life.13

Factors that have been identified as being important for sustaining cultures that ensure safe and high-quality care include14-15:• Leaders articulating a vision for high-quality,

compassionate and safe care, and acting on this vision throughout the organisation

• Translating the vision into clear objectives for safety and quality at all levels of the organisation, and establishing measures to assess progress

• Providing a supportive and positive working environment for the workforce

• Ensuring that members of the workforce are engaged in their work

• Having an organisation that is transparent about performance, open to learning and continuously improving

• Supporting multidisciplinary teams to work together effectively.

To put in place the requirements of the NSQHS Standards that are the basis of the Clinical Governance Framework, health service organisations need to have a culture that has16:• Strong strategic and cultural leadership of

clinical services, focusing on – effective planning to enable development and

improvement opportunities to be captured – cultural leadership that requires, and gives

priority to, safety and quality, and supports continuous improvement

– allocating resources to support the delivery of high-quality care

• Clear responsibilities for managing the safety and quality of care, and delegation of the necessary management authority for this purpose

• Reliable processes for ensuring that systems for delivery of care are designed and performing well, and clinicians are fully engaged in the design, monitoring and development of these systems

• Effective use of data and information to monitor and report on performance, through the health service organisation to the governing body

• Well-designed systems for identifying and managing clinical risk.


Roles and responsibilities for clinical governance

Good clinical governance provides confidence to the community and everyone who works in a health service organisation that systems are in place to support the delivery of safe, high-quality health care. Within a well-governed healthcare organisation, everyone, including frontline clinicians, managers and the governing body, is accountable for their contribution to the safety and quality of care delivered to patients. Broadly, these roles are as follows (Figure 4):• Patients and consumers

Patients and consumers participate as partners to the extent that they choose. These partnerships can be in their own care, and in organisational design and governance.

• Clinicians Clinicians work within, and are supported by, well-designed clinical systems to deliver safe, high-quality clinical care. Clinicians are responsible for the safety and quality of their own professional practice, and professional codes of conduct include requirements that align with the Clinical Governance Framework.17

• Managers Managers (including clinical managers) advise and inform the governing body, and operate the organisation within the strategic and policy parameters endorsed by the governing body. They are primarily responsible for ensuring that the systems that support the delivery of care are well designed and perform well.

• Governing body The governing body is ultimately responsible for ensuring that the organisation is run well and delivers safe, high-quality care. It does this by establishing a strong safety culture through an effective clinical governance system, satisfying itself that this system operates effectively, and ensuring that there is an ongoing focus on quality improvement.

In addition to these roles, state and territory departments of health provide centralised and coordinated oversight of the performance of health service organisations, and create a common set of safety metrics that report meaningful safety and quality outcomes.

Implementation of an organisation’s clinical governance system involves contributions by individuals and teams at all levels of the organisation. Roles and responsibilities for clinical governance at all levels of the system are summarised in the following sections.


Figure 4: Clinical governance roles


Governance, leadership and culture

The roles and responsibilities for this component of the Clinical Governance Framework relate to the establishment of, and participation in, corporate and clinical governance systems.

Role Responsibilities

Patients and consumers

• Use organisational systems and processes to contribute to the planning, design and operation of the health service organisation

• Identify opportunities for improvement of the health service organisation and communicate these to relevant individuals or bodies

• Consider taking an active role in the governance of the health service organisation, when opportunities exist

Clinicians • Actively take part in the development of an organisational culture that enables, and gives priority to, patient safety and quality

• Actively communicate their profession’s commitment to the delivery of safe, high-quality health care

• Model professional conduct that is consistent with a commitment to safety and quality at all times

• Embrace opportunities to learn about safety and quality theory and systems

• Embrace opportunities to take part in the management of clinical services

• Encourage, mentor and guide colleagues in the delivery of safe, high-quality care

• Take part in all aspects of the development, implementation, evaluation and monitoring of governance processes

Managers (including clinical managers)

• Actively communicate the commitment of the health service organisation to the delivery of safe, high-quality care

• Create opportunities for the workforce to receive education in safety and quality theory and systems

• Model the safety and quality values of the health service organisation in all aspects of management

• Support clinicians who embrace clinical leadership roles

• Lead the development of business plans, strategic plans, and organisational policies and procedures relevant to safety and quality

• Integrate safety and quality into organisational plans, policies and procedures

• Set up effective relationships with relevant health services to support good clinical outcomes



Governing bodies

• Lead development of a common organisational language in safety, quality and clinical governance

• Actively communicate the commitment of the governing body to the delivery of safe, high-quality care

• Are satisfied that an effective culture of safety and quality exists within the health service organisation

• Lead the organisation towards achieving a ‘blame-free’, accountable and learning culture

• Are aware of how the health service organisation sits within a wider network of local and other health services and providers

• Set up an effective relationship with the chief executive officer, founded on a mutual commitment to safety and quality of care

• Ensure that the organisation has a comprehensive suite of plans, strategies and policies that support safety and quality of care

• Ensure that organisational resources are allocated to support safety and quality of care

• Create relevant education and training opportunities for managers and executives

• Allocate enough board time and attention to safety and quality of care

• Monitor organisational culture, and identify and capture improvement opportunities and ensure that they are acted on

Patient safety and quality improvement systems

Roles and responsibilities for this component of the Clinical Governance Framework relate to the various patient safety and quality processes that are part of effective clinical governance systems.



• Provide feedback, complaints and compliments about experiences in the health service organisation, including

– participating in patient experience surveys

– communicating with the organisation about any opportunities for improving services and systems

– communicating with the organisation about potential safety and quality risks

• Consider being involved in quality improvement projects within the health service organisation

• Consider advocating for, or representing, other patients in focus groups and meetings to improve the health service organisation and the care that is delivered

• Consider reviewing and commenting on reports on safety and quality of the health service organisation

• Consider participating in the review of safety and quality incidents or other serious adverse events, when opportunities exist



Clinicians • Contribute to the design of systems for the delivery of safe, high-quality clinical care

• Provide clinical care within the parameters of these systems

• Communicate with clinicians in other health service organisations to support good clinical outcomes

• Ensure contemporary knowledge about safe system design

• Maintain vigilance for opportunities to improve systems

• Ensure that identified opportunities for improvement are raised and reported appropriately

• Educate junior clinicians in the importance of working within the organisational systems for the delivery of clinical care

• Take part in the design and implementation of systems within the health service organisation for

– quality improvement and measurement

– risk management

– incident management

– open disclosure

– feedback and complaints management

• Comply with professional regulatory requirements and codes of conduct


• Coordinate and oversee the design of systems for the delivery of clinical care

• Engage with clinicians on all system design issues

• Allocate appropriate resources to implement well-designed systems of care

• Respond to identified concerns about the design of systems

• Periodically, systematically review the design of systems for safety and quality

• Set up an operational policy and procedure framework, with the active engagement of clinicians

• Ensure availability of data and information to clinicians to support quality assurance and improvement

• Ensure that safety and quality systems reflect the role of the health service organisation within a wider network of local and other health services and providers

• Implement and resource effective systems for management of


– risk management


– open disclosure

– feedback and complaints

• Systematically monitor performance across all safety and quality systems

• Report to the health service organisation and governing body



Governing bodies

• Ensure that all systems for the delivery of care are regularly reviewed for their ability to support safe, high-quality care

• Incorporate systematic audits of safety and quality systems in the whole-of-organisation audit program

• Ensure availability of data and information to support quality assurance and review across the organisation

• Monitor system performance, and consider implications for system design and opportunities for improvement

• Ensure that the following safety and quality systems are in place, involve all members of the clinical workforce and are subject to periodic review of performance


– risk management


– open disclosure

– feedback and complaints management

Clinical performance and effectiveness

Roles and responsibilities for this component of the Clinical Governance Framework relate to the processes that exist in effective clinical governance systems for ensuring that the workforce has the right qualifications, skills and supervision to deliver safe and high-quality care.



• Provide feedback, complaints and compliments about experiences in the health service, including


– communicating with the organisation about any opportunities for improving services and systems


• Consider sharing experiences through patient stories, information sessions, letters, pictures, patient journeys, or presentations at meetings or training sessions for the workforce

• Consider participating in recruitment processes for the workforce, when opportunities exist



Clinicians • Maintain personal professional skills, competence and performance

• Contribute to relevant organisational policies and procedures

• Comply with professional regulatory requirements and codes of conduct

• Monitor personal clinical performance

• Supervise and manage the performance of junior clinicians

• Ensure that specific performance concerns are reported appropriately

• Work constructively in clinical teams

• Take part in the design and implementation of the organisation’s systems for

– credentialing and defining scope of clinical practice

– clinical education and training

– performance monitoring and management

– clinical, and safety and quality education and training


• Maintain personal professional skills, competence and performance

• Set up an operational policy and procedure framework

• Implement and resource effective systems for management of




– clinical, and safety and quality education and training

• Respond in a prompt and effective way to indications of clinical underperformance

• Systematically monitor safety and quality performance across all clinical

Governing bodies

• Ensure that the following organisational systems are in place, involve all members of the clinical workforce and are subject to periodic review of system performance




– whole-of-organisation clinical, and safety and quality education and training


Safe environment for the delivery of care

Roles and responsibilities for this component of the Clinical Governance Framework relate to the creation of an environment that supports safety and quality.



• Provide feedback, complaints and compliments about experiences of the environment of the health service organisation, including


– communicating with the organisation about any opportunities for improving the environment


• Consider being involved in quality improvement projects within the health service organisation

Clinicians • Contribute to planning and development activities regarding the environment of the health service organisation

• Provide clinical care within the parameters of this environment

• Maintain vigilance for opportunities to improve the environment

• Ensure that identified opportunities for improvement are raised and reported appropriately


• Coordinate and oversee planning and development of the health service environment to support safety and quality

• Engage with clinicians on the environment of the health service organisation

• Allocate appropriate resources to ensure that the environment supports safety and quality

• Respond to identified concerns about the environment

Governing bodies

• Ensure that the environment of the health service organisation promotes safe and high-quality care


Partnering with consumers

Roles and responsibilities for this component of the Clinical Governance Framework relate to the way in which patients and consumers are involved in partnerships in their own care, and in organisational design and governance.



• Are involved in planning and sharing decisions about individual health care

• Ask for more information, information in different formats or a translator, if required

• Let the workforce know who should be involved in sharing decisions about their care

• Provide feedback to the health service organisation or clinician about care experiences

• Consider being involved in the governance of the organisation, when opportunities exist

• Consider being involved in the development and review of health information for consumers, when opportunities exist

Clinicians • Understand the evidence on consumer engagement, and its contribution to the safety and quality of health care

• Understand how health literacy might affect the way a consumer gains access to, understands and uses health information

• Support patients to have access to, and use, high-quality, easy-to-understand information about health care

• Support patients to share decision-making about their own health care, to the extent that they choose

• Work with consumer representative groups to ensure that systems of care are designed to encourage consumer engagement in decision-making

• Assist consumer access to their own health information, and complaints and feedback systems

• Implement and fully take part in the organisation’s open disclosure policy


• Understand the barriers for patients and consumers to understand and use health services, and develop strategies to improve the health literacy environment of the health service organisation

• Ensure that patients and consumers have access to high-quality, easy-to-understand information about health care

• Set up organisational systems to enable consumers to fully engage in

– planning and sharing decisions about their own health care

– planning, designing, reviewing and evaluating clinical systems, and safety and quality of care

• Collect and review patient experience information as part of quality improvement processes

• Create opportunities for consumer involvement in relevant operational committees

• When appropriate, set up specific consumer advisory committees



Governing bodies

• Show leadership and commitment to partnerships with consumers

• Set up high-level policies and procedures that support partnerships with consumers

• Ensure that the organisation has effective systems for consumer complaints and open disclosure, and monitor performance of these systems

• Ensure consumer input to decisions of the governing body

• Create opportunities for consumer involvement in subcommittees of the governing body

• Ensure that organisational systems support consumer engagement in decision-making

• When appropriate, set up a specific consumer advisory committee to the board


Appendix: NSQHS Standards

The second edition of the NSQHS Standards has eight standards:1. Clinical Governance

2. Partnering with Consumers

3. Preventing and Controlling Healthcare-Associated Infection

4. Medication Safety

5. Comprehensive Care

6. Communicating for Safety

7. Blood Management

8. Recognising and Responding to Acute Deterioration.

Within the context of all of these standards, the Clinical Governance Framework comprises the Clinical Governance Standard and the Partnering with Consumers Standard. This appendix lists the actions in these two standards, and provides some background information about the rationale and context for each standard.

1. Clinical Governance Standard

Although most health care in Australia is associated with good clinical outcomes, patients do not always receive the care that is recommended, and adverse events continue to occur across the Australian healthcare system.2

Estimates of the proportion of patients who experience patient safety incidents in hospital range from 3% to 15% of admissions.18-21 This variation occurs because of differences in definitions and methods of collecting information. Even if the lower, more conservative, rate of 3% is used, this means that almost 300,000 people were affected by a patient safety incident in a hospital in Australia in 2013–14.22

Patient safety incidents can be associated with adverse outcomes for the patient, such as pain, delays in care, short-term and permanent disabilities (both physical and psychological), and death. They can also be associated with increased healthcare costs due to longer hospital stays, extra treatments and readmissions.2

Although it is difficult to measure the costs directly attributable to lapses in safety and quality in health care, estimates indicate that the costs are considerable. Almost a decade ago, the National Health and Hospitals Reform Commission estimated that ‘adverse events cost around $2 billion annually’.23

The case for investing in improvements in the safety and quality of care in the Australian healthcare system is strong. A rigorous safety and quality framework that addresses system-level issues can reduce the cost of poor care and reduce harm to patients.

A systematic approach to quality improvement identifies those accountable for specific actions in health service organisations, and focuses on safety and quality risks to ensure that the necessary monitoring and actions are taken to improve services. Safe and high-quality care requires the vigilance and cooperation of the whole healthcare workforce.

In recent years, health service organisations have used the NSQHS Standards as a framework for investing in safety and quality improvement activities, such as developing and implementing policies, educational materials and improvement processes (including credentialing, mortality reviews, incident monitoring and root-cause analysis). These changes have improved the safety and quality of health care for patients.24



Leaders at all levels in the organisation set up and use clinical governance systems to improve the safety and quality of health care for patients.

Item Action


1.1 The governing body:

a. Provides leadership to develop a culture of safety and quality improvement, and satisfies itself that this culture exists within the organisation

b. Provides leadership to ensure partnering with patients, carers and consumers

c. Sets priorities and strategic directions for safe and high-quality clinical care, and ensures that these are communicated effectively to the workforce and the community

d. Endorses the organisation’s clinical governance framework

e. Ensures that roles and responsibilities are clearly defined for the governing body, management, clinicians and the workforce

f. Monitors the action taken as a result of analyses of clinical incidents

g. Reviews reports and monitors the organisation’s progress on safety and quality performance

1.2 The governing body ensures that the organisation’s safety and quality priorities address the specific health needs of Aboriginal and Torres Strait Islander people

Organisational leadership

1.3 The health service organisation establishes and maintains a clinical governance framework, and uses the processes within the framework to drive improvements in safety and quality

1.4 The health service organisation implements and monitors strategies to meet the organisation’s safety and quality priorities for Aboriginal and Torres Strait Islander people

1.5 The health service organisation considers the safety and quality of health care for patients in its business decision-making

Clinical leadership 1.6 Clinical leaders support clinicians to:

a. Understand and perform their delegated safety and quality roles and responsibilities

b. Operate within the clinical governance framework to improve the safety and quality of health care for patients


Patient safety and quality systems

Safety and quality systems are integrated with governance processes to enable organisations to actively manage and improve the safety and quality of health care for patients.

Item Action

Policies and procedures

1.7 The health service organisation uses a risk management approach to:

a. Set out, review, and maintain the currency and effectiveness of, policies, procedures and protocols

b. Monitor and take action to improve adherence to policies, procedures and protocols

c. Review compliance with legislation, regulation and jurisdictional requirements

Measurement and quality improvement

1.8 The health service organisation uses organisation-wide quality improvement systems that:

a. Identify safety and quality measures, and monitor and report performance and outcomes

b. Identify areas for improvement in safety and quality

c. Implement and monitor safety and quality improvement strategies

d. Involve consumers and the workforce in the review of safety and quality performance and systems

1.9 The health service organisation ensures that timely reports on safety and quality systems and performance are provided to:

a. The governing body

b. The workforce

c. Consumers and the local community

d. Other relevant health service organisations

Risk management 1.10 The health service organisation:

a. Identifies and documents organisational risks

b. Uses clinical and other data collections to support risk assessments

c. Acts to reduce risks

d. Regularly reviews and acts to improve the effectiveness of the risk management system

e. Reports on risks to the workforce and consumers

f. Plans for, and manages, internal and external emergencies and disasters


Item Action

Incident management systems and open disclosure

1.11 The health service organisation has organisation-wide incident management and investigation systems, and:

a. Supports the workforce to recognise and report incidents

b. Supports patients, carers and families to communicate concerns or incidents

c. Involves the workforce and consumers in the review of incidents

d. Provides timely feedback on the analysis of incidents to the governing body, the workforce and consumers

e. Uses the information from the analysis of incidents to improve safety and quality

f. Incorporates risks identified in the analysis of incidents into the risk management system

g. Regularly reviews and acts to improve the effectiveness of the incident management and investigation systems

1.12 The health service organisation:

a. Uses an open disclosure program that is consistent with the Australian Open Disclosure Framework25

b. Monitors and acts to improve the effectiveness of open disclosure processes

Feedback and complaints management


a. Has processes to seek regular feedback from patients, carers and families about their experiences and outcomes of care

b. Has processes to regularly seek feedback from the workforce on their understanding and use of the safety and quality systems

c. Uses this information to improve safety and quality systems

1.14 The health service organisation has an organisation-wide complaints management system, and:

a. Encourages and supports patients, carers and families, and the workforce to report complaints

b. Involves the workforce and consumers in the review of complaints

c. Resolves complaints in a timely way

d. Provides timely feedback to the governing body, the workforce and consumers on the analysis of complaints and actions taken

e. Uses information from the analysis of complaints to inform improvements in safety and quality systems

f. Records the risks identified from the analysis of complaints in the risk management system

g. Regularly reviews and acts to improve the effectiveness of the complaints management system


Item Action

Diversity and high-risk groups


a. Identifies the diversity of the consumers using its services

b. Identifies groups of patients using its services who are at higher risk of harm

c. Incorporates information on the diversity of its consumers and higher-risk groups into the planning and delivery of care

Healthcare records

1.16 The health service organisation has healthcare records systems that:

a. Make the healthcare record available to clinicians at the point of care

b. Support the workforce to maintain accurate and complete healthcare records

c. Comply with security and privacy regulations

d. Support systematic audit of clinical information

e. Integrate multiple information systems, where they are used

1.17 The health service organisation works towards implementing systems that can provide clinical information into the My Health Record system that:

a. Are designed to optimise the safety and quality of health care for patients

b. Use national patient and provider identifiers

c. Use standard national terminologies

1.18 The health service organisation providing clinical information into the My Health Record system has processes that:

a. Describe access to the system by the workforce, to comply with legislative requirements

b. Maintain the accuracy and completeness of the clinical information the organisation uploads into the system


Clinical performance and effectiveness

The workforce has the right qualifications, skills and supervision to provide safe, high-quality health care to patients.

Item Action

Safety and quality training

1.19 The health service organisation provides orientation to the organisation that describes roles and responsibilities for safety and quality for:

a. Members of the governing body

b. Clinicians, and any other employed, contracted, locum, agency, student or volunteer members of the organisation

1.20 The health service organisation uses its training systems to:

a. Assess the competency and training needs of its workforce

b. Implement a mandatory training program to meet its requirements arising from these standards

c. Provide access to training to meet its safety and quality training needs

d. Monitor the workforce’s participation in training

1.21 The health service organisation has strategies to improve the cultural awareness and cultural competency of the workforce to meet the needs of its Aboriginal and Torres Strait Islander patients

Performance management

1.22 The health service organisation has valid and reliable performance review processes that:

a. Require members of the workforce to regularly take part in a review of their performance

b. Identify needs for training and development in safety and quality

c. Incorporate information on training requirements into the organisation’s training system

Credentialing and scope of clinical practice

1.23 The health service organisation has processes to:

a. Define the scope of clinical practice for clinicians, considering the clinical service capacity of the organisation and clinical services plan

b. Monitor clinicians’ practices to ensure that they are operating within their designated scope of clinical practice

c. Review the scope of clinical practice of clinicians periodically and whenever a new clinical service, procedure or technology is introduced or substantially altered


a. Conducts processes to ensure that clinicians are credentialed, where relevant

b. Monitors and improves the effectiveness of the credentialing process


Item Action

Safety and quality roles and responsibilities

1.25 The health service organisation has processes to:

a. Support the workforce to understand and perform their roles and responsibilities for safety and quality

b. Assign safety and quality roles and responsibilities to the workforce, including locums and agency staff

1.26 The health service organisation provides supervision for clinicians to ensure that they can safely fulfil their designated roles, including access to after-hours advice, where appropriate

Evidence-based care

1.27 The health service organisation has processes that:

a. Provide clinicians with ready access to best-practice guidelines, integrated care pathways, clinical pathways and decision support tools relevant to their clinical practice

b. Support clinicians to use the best available evidence, including relevant clinical care standards developed by the Australian Commission on Safety and Quality in Health Care

Variation in clinical practice and health outcomes

1.28 The health service organisation has systems to:

a. Monitor variation in practice against expected health outcomes

b. Provide feedback to clinicians on variation in practice and health outcomes

c. Review performance against external measures

d. Support clinicians to participate in clinical review of their practice

e. Use information on unwarranted clinical variation to inform improvements in safety and quality systems

f. Record the risks identified from unwarranted clinical variation in the risk management system


Safe environment for the delivery of care

The environment promotes safe and high-quality health care for patients.

Item Action

Safe environment 1.29 The health service organisation maximises safety and quality of care:

a. Through the design of the environment

b. By maintaining buildings, plant, equipment, utilities, devices and other infrastructure that are fit for purpose


a. Identifies service areas that have a high risk of unpredictable behaviours and develops strategies to minimise the risks of harm for patients, carers, families, consumers and the workforce

b. Provides access to a calm and quiet environment when it is clinically required

1.31 The health service organisation facilitates access to services and facilities by using signage and directions that are clear and fit for purpose

1.32 The health service organisation admitting patients overnight has processes that allow flexible visiting arrangements to meet patients’ needs, when it is safe to do so

1.33 The health service organisation demonstrates a welcoming environment that recognises the importance of the cultural beliefs and practices of Aboriginal and Torres Strait Islander people


2. Partnering with Consumers Standard

Effective partnerships exist when people are treated with dignity and respect, information is shared with them, and participation and collaboration in healthcare processes are encouraged and supported to the extent that people choose.26

The health system includes different types of partnerships, which are not mutually exclusive. Partnerships are necessary at all levels to ensure that a health service organisation achieves the best possible outcomes for all parties.27

At the level of the individual, partnerships relate to the interaction between clinicians and patients when care is provided. At this level, a partnership involves providing care that is respectful; sharing information in an ongoing way; working with patients, carers and families to make decisions and plan care; and supporting and encouraging patients in their own care.

At the level of a service, department or program of care, partnerships relate to the organisation and delivery of care within specific areas. At this level, a partnership involves the participation of patients, carers, families and consumers in the overall design of the service, department or program. This could be as full members of quality improvement and redesign teams, and participating in planning, implementing and evaluating change.

At the level of the health service, partnerships relate to the involvement of consumers in overall governance, policy and planning. This level overlaps with the previous level, since a health service is made up of various services, departments and programs. At the level of the health service, partnerships relate to the involvement of consumers and consumer representatives as full members of key organisational governance committees in areas such as patient safety, facility design, quality improvement, patient or family education, ethics and research. This level can also involve partnerships with local community organisations and members of local communities.

Delivering care that is based on partnerships provides many benefits for patients, consumers, clinicians, health service organisations and the health system. There is evidence for links between the existence of effective partnerships, a positive experience for patients, and high-quality health care and improved safety.27-29 As well, the involvement of patients and consumers in planning, delivery, monitoring and evaluation can have a positive impact on service planning and development, information development and dissemination, and the attitudes of healthcare providers.27,30,31 Specific studies in the United States have found that delivering health care that is based on partnerships can result in reduced hospital costs, lower cost per case and reduced length of stay.32,33


Clinical governance and quality improvement systems to support partnering with consumers

Systems are designed and used to support patients, carers, families and consumers to be partners in healthcare planning, design, measurement and evaluation.

Item Action

Integrating clinical governance

2.1 Clinicians use the safety and quality systems from the Clinical Governance Standard when:

a. Implementing policies and procedures for partnering with consumers

b. Managing risks associated with partnering with consumers

c. Identifying training requirements for partnering with consumers

Applying quality improvement systems

2.2 The health service organisation applies the quality improvement system in the Clinical Governance Standard when:

a. Monitoring processes for partnering with consumers

b. Implementing strategies to improve processes for partnering with consumers

c. Reporting on partnering with consumers

Partnering with patients in their own care

Systems that are based on partnering with patients in their own care are used to support the delivery of care. Patients are partners in their own care to the extent that they choose.

Item Action

Healthcare rights and informed consent

2.3 The health service organisation uses a charter of rights that is:

a. Consistent with the Australian Charter of Healthcare Rights34

b. Easily accessible for patients, carers, families and consumers

2.4 The health service organisation ensures that its informed consent processes comply with legislation and best practice

2.5 The health service organisation has processes to identify:

a. The capacity of a patient to make decisions about their own care

b. A substitute decision-maker if a patient does not have the capacity to make decisions for themselves

Sharing decisions and planning care

2.6 The health service organisation has processes for clinicians to partner with patients and/or their substitute decision-maker to plan, communicate, set goals, and make decisions about their current and future care

2.7 The health service organisation supports the workforce to form partnerships with patients and carers so that patients can be actively involved in their own care


Health literacy

Health service organisations communicate with consumers in a way that supports effective partnerships.

Item Action

Communication that supports effective partnerships

2.8 The health service organisation uses communication mechanisms that are tailored to the diversity of the consumers who use its services and, where relevant, the diversity of the local community

2.9 Where information for patients, carers, families and consumers about health and health services is developed internally, the organisation involves consumers in its development and review

2.10 The health service organisation supports clinicians to communicate with patients, carers, families and consumers about health and health care so that:

a. Information is provided in a way that meets the needs of patients, carers, families and consumers

b. Information provided is easy to understand and use

c. The clinical needs of patients are addressed while they are in the health service organisation

d. Information needs for ongoing care are provided on discharge

Partnering with consumers in organisational design and governance

Consumers are partners in the design and governance of the organisation.

Item Action

Partnerships in healthcare governance planning, design, measurement and evaluation


a. Involves consumers in partnerships in the governance of, and to design, measure and evaluate, health care

b. Has processes so that the consumers involved in these partnerships reflect the diversity of consumers who use the service or, where relevant, the diversity of the local community

2.12 The health service organisation provides orientation, support and education to consumers who are partnering in the governance, design, measurement and evaluation of the organisation

2.13 The health service organisation works in partnership with Aboriginal and Torres Strait Islander communities to meet their healthcare needs

2.14 The health service organisation works in partnership with consumers to incorporate their views and experiences into training and education for the workforce


Acknowledgements

The Clinical Governance Framework was developed with input from the National Model Clinical Governance Advisory Panel. Members of this panel are listed below. The Commission thanks the members of the panel for their time and expertise.

Name Position

Ms Wendy Harris QC, Chair Australian Commission on Safety and Quality in Health Care

Dr Richard Ashby AM Chief Executive, Metro South Hospital and Health Service, Queensland

Dr Tarun Bastiampillai Representative, Australian Medical Association (South Australia)

Adjunct Professor Cheyne Chalmers Chief Nursing and Midwifery Officer, Monash Health

Dr Michael Coglin Representative, private sector provider

Ms Karen Crawshaw PSM Deputy Secretary, NSW Ministry of Health

Mr Martin Fletcher Chief Executive Officer, Australian Health Practitioner Regulation Agency

Professor Phillip Harris Chair, South Western Sydney Local Health District

Ms Sally-Anne Jones Federal President, Australian Nursing and Midwifery Federation

Professor Anthony Lawler President, Australasian College for Emergency Medicine; and Principal Medical Advisor, Tasmanian Department of Health and Human Services

Dr Len Notaras AM Chief Executive, Northern Territory Department of Health

Ms Jenny Richter Deputy Chief Executive, SA Health

Mrs Cheryle Royle General Manager, St Vincent’s Private Hospital, Queensland

Professor David Watters OBE President, Royal Australasian College of Surgeons

Ms Jennifer Westacott Chief Executive, Business Council of Australia

Associate Professor Andrew Wilson Chief Medical Officer, Victoria Health

Dr Chris Zappala President, Australian Medical Association (Queensland)


Glossary

If appropriate, glossary definitions from external sources have been adapted to fit the context of the NSQHS Standards.

adverse event: an incident that results, or could have resulted, in harm to a patient or consumer. A near miss is a type of adverse event. See also near miss

Australian Charter of Healthcare Rights: specifies the key rights of patients when seeking or receiving healthcare services. It was endorsed by health ministers in 2008.34

Australian Open Disclosure Framework: endorsed by health ministers in 2013, it provides a framework for health service organisations and clinicians to communicate openly with patients when health care does not go to plan.25

clinical governance: an integrated component of corporate governance of health service organisations. It ensures that everyone – from frontline clinicians to managers and members of governing bodies, such as boards – is accountable to patients and the community for assuring the delivery of safe, effective and high-quality services. Clinical governance systems provide confidence to the community and the healthcare organisation that systems are in place to deliver safe and high-quality health care.

clinical leaders: clinicians with management or leadership roles in a health service organisation who can use their position or influence to change behaviour, practice or performance. Examples are directors of clinical services, heads of units and clinical supervisors.

clinician: a healthcare provider, trained as a health professional, including registered and non-registered practitioners. Clinicians may provide care within a health service organisation as an employee, a contractor or a credentialed healthcare provider, or under other working arrangements. They include nurses, midwives, medical practitioners, allied health practitioners, technicians, scientists and other clinicians who provide health care, and students who provide health care under supervision.

consumer: a person who has used, or may potentially use, health services, or is a carer for a patient using health services. A healthcare consumer may also act as a consumer representative, to provide a consumer perspective, contribute consumer experiences, advocate for the interests of current and potential health service users, and take part in decision-making processes.35

credentialing: the formal process used by a health service organisation to verify the qualifications, experience, professional standing, competencies and other relevant professional attributes of clinicians, so that the organisation can form a view about the clinician’s competence, performance and professional suitability to provide safe, high-quality healthcare services within specific organisational environments.36

environment: the physical surroundings in which health care is delivered, including the building, fixtures, fittings, and services such as air and water supply. Environment can also include other patients, consumers, visitors and the workforce.

governance: the set of relationships and responsibilities established by a health service organisation between its executive, workforce and stakeholders (including patients and consumers). Governance incorporates the processes, customs, policy directives, laws and conventions affecting the way an organisation is directed, administered or controlled. Governance arrangements provide the structure for setting the corporate objectives (social, fiscal, legal, human resources) of the organisation and the means to achieve the objectives. They also specify the mechanisms for monitoring performance. Effective governance provides a clear statement of individual accountabilities within the organisation to help align the roles, interests and actions of different participants in the organisation to achieve the organisation’s objectives. In the NSQHS Standards, governance includes both corporate and clinical governance.


governing body: a board, chief executive officer, organisation owner, partnership or other highest level of governance (individual or group of individuals) that has ultimate responsibility for strategic and operational decisions affecting safety and quality in a health service organisation.

health care: the prevention, treatment and management of illness and injury, and the preservation of mental and physical wellbeing through the services offered by clinicians, such as medical, nursing and allied health professionals.25

healthcare record: includes a record of the patient’s medical history, treatment notes, observations, correspondence, investigations, test results, photographs, prescription records and medication charts for an episode of care.

health literacy: the Australian Commission on Safety and Quality in Health Care separates health literacy into two components – individual health literacy and the health literacy environment.

Individual health literacy is the skills, knowledge, motivation and capacity of a consumer to access, understand, appraise and apply information to make effective decisions about health and health care, and take appropriate action.

The health literacy environment is the infrastructure, policies, processes, materials, people and relationships that make up the health system, which affect the ways in which consumers access, understand, appraise and apply health-related information and services.37

health service organisation: a separately constituted health service that is responsible for implementing clinical governance, administration and financial management of a service unit or service units providing health care at the direction of the governing body. A service unit involves a group of clinicians and others working in a systematic way to deliver health care to patients. It can be in any location or setting, including pharmacies, clinics, outpatient facilities, hospitals, patients’ homes, community settings, practices and clinicians’ rooms.

higher risk (patients at higher risk of harm): a patient with multiple factors or a few specific factors that result in their being more vulnerable to harm from health care or the healthcare system. Risk factors may include having chronic clinical conditions; having language barriers; being of Aboriginal or Torres Strait Islander background;

having low health literacy; being homeless; or being of diverse gender identities and experiences, bodies, relationships and sexualities (currently referred to as lesbian, gay, bisexual, transgender and intersex, or LGBTI).

incident (clinical): an event or circumstance that resulted, or could have resulted, in unintended or unnecessary harm to a patient or consumer; or a complaint, loss or damage. An incident may also be a near miss. See also near miss

informed consent: a process of communication between a patient and a clinician about options for treatment, care processes or potential outcomes. This communication results in the patient’s authorisation or agreement to undergo a specific intervention or participate in planned care.38 The communication should ensure that the patient has an understanding of the care they will receive, all the available options and the expected outcomes, including success rates and side effects for each option.39

jurisdictional requirements: systematically developed statements from state and territory governments about appropriate healthcare or service delivery for specific circumstances.40

Jurisdictional requirements encompass a number of types of documents from state and territory governments, including legislation, regulations, guidelines, policies, directives and circulars. Terms used for each document may vary by state and territory.

leadership: having a vision of what can be achieved, and then communicating this to others and evolving strategies for realising the vision. Leaders motivate people, and can negotiate for resources and other support to achieve goals.41

local community: the people living in a defined geographic region or from a specific group who receive services from a health service organisation.

near miss: an incident or potential incident that was averted and did not cause harm, but had the potential to do so.42

open disclosure: an open discussion with a patient and carer about an incident that resulted in harm to the patient while receiving health care. The criteria of open disclosure are an expression of regret, and a factual explanation of what happened, the potential consequences, and the steps taken to manage the event and prevent recurrence.43


organisation-wide: intended for use throughout the health service organisation.

outcome: the status of an individual, group of people or population that is wholly or partially attributable to an action, agent or circumstance.44

partnership: a situation that develops when patients and consumers are treated with dignity and respect, when information is shared with them, and when participation and collaboration in healthcare processes are encouraged and supported to the extent that patients and consumers choose. Partnerships can exist in different ways in a health service organisation, including at the level of individual interactions; at the level of a service, department or program; and at the level of the organisation. They can also exist with consumers and groups in the community. Generally, partnerships at all levels are necessary to ensure that the health service organisation is responsive to patient and consumer input and needs, although the nature of the activities for these different types of partnership will vary depending on the context of the health service organisation.

patient: a person who is receiving care in a health service organisation.

patient safety: prevention of errors and adverse effects on patients associated with health care.

policy: a set of principles that reflect the organisation’s mission and direction. All procedures and protocols are linked to a policy statement.

procedure: the set of instructions to make policies and protocols operational, which are specific to an organisation.

process: a series of actions or steps taken to achieve a particular goal.45

program: an initiative, or series of initiatives, designed to deal with a particular issue, with resources, a time frame, objectives and deliverables allocated to it.

protocol: an established set of rules used to complete tasks or a set of tasks.

quality improvement: the combined efforts of the workforce and others – including consumers, patients and their families, researchers, planners and educators – to make changes that will lead to better patient outcomes (health), better system performance (care) and better professional development.46 Quality improvement activities may be undertaken in sequence, intermittently or on a continual basis.

risk: the chance of something happening that will have a negative impact. Risk is measured by the consequences of an event and its likelihood.

risk assessment: the assessment, analysis and management of risks. It involves recognising which events may lead to harm in the future, and minimising their likelihood and consequence.47

risk management: the design and implementation of a program to identify and avoid or minimise risks to patients, employees, volunteers, visitors and the organisation.

safety culture: a commitment to safety that permeates all levels of an organisation, from the clinical workforce to executive management. Features commonly include acknowledgement of the high-risk, error-prone nature of an organisation’s activities; a blame-free environment in which individuals are able to report errors or near misses without fear of reprimand or punishment; an expectation of collaboration across all areas and levels of an organisation to seek solutions to vulnerabilities; and a willingness of the organisation to direct resources to deal with safety concerns.48

scope of clinical practice: the extent of an individual clinician’s approved clinical practice within a particular organisation, based on the clinician’s skills, knowledge, performance and professional suitability, and the needs and service capability of the organisation.16

standard: agreed attributes and processes designed to ensure that a product, service or method will perform consistently at a designated level.44


system: the resources, policies, processes and procedures that are organised, integrated, regulated and administered to accomplish a stated goal. A system: • Brings together risk management, governance

and operational processes and procedures, including education, training and orientation

• Deploys an active implementation plan; feedback mechanisms include agreed protocols and guidelines, decision support tools and other resource materials

• Uses several incentives and sanctions to influence behaviours and encourage compliance with policy, protocol, regulation and procedures.

The workforce is both a resource in the system and involved in all elements of systems development, implementation, monitoring, improvement and evaluation.

training: the development of knowledge and skills.

workforce: all people working in a health service organisation, including clinicians, and any other employed or contracted, locum, agency, student, volunteer or peer workers. The workforce can be members of the health service organisation or medical company representatives providing technical support who have assigned roles and responsibilities for care of, administration of, support of, or involvement with, patients in the health service organisation. See also clinician


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